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Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

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ClinicalTrials.gov Identifier: NCT00802412
Recruitment Status : Completed
First Posted : December 4, 2008
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

December 3, 2008
December 4, 2008
September 27, 2016
January 31, 2017
January 31, 2017
January 2009
November 2014   (Final data collection date for primary outcome measure)
4-week Continuous Abstinence From Smoking [ Time Frame: Weeks 8-12 of treatment. ]
This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.
4-week Continuous Abstinence From Smoking [ Time Frame: End of treatment ]
Complete list of historical versions of study NCT00802412 on ClinicalTrials.gov Archive Site
Percent Relapsing to Any Drinking or Illicit Drug Use [ Time Frame: 12-week treatment phase, 36-week combined treatment and follow-up ]
Alcohol or illicit drug use during treatment or follow up.
Percent relapsing to any drinking [ Time Frame: 12-week treatment phase, 36-week combined treatment and follow-up ]
Not Provided
Not Provided
 
Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.
This study is a 12-week, double-blind, placebo-controlled trial to test the efficacy of topiramate versus placebo as an aid to smoking cessation for recovering alcohol dependent men. Another aim of the study is to explore whether or not topiramate reduces relapse to alcohol use in patients with comorbid alcohol and nicotine dependence. All participants will receive a standardized psychosocial intervention in combination with the medication (or placebo). Following completion of the treatment phase of the study, participants will enter a 24-week follow-up period during which the longer-term outcome of the intervention will be assessed.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Nicotine Dependence
  • Alcohol Dependence
  • Drug: Topiramate
    Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).
    Other Name: Topamax
  • Drug: Placebo
    Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.
  • Topiramate
    The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.
    Intervention: Drug: Topiramate
  • Placebo Comparator: Placebo
    90 participants, will receive matching placebo
    Intervention: Drug: Placebo
Anthenelli RM, Heffner JL, Wong E, Tibbs J, Russell K, Isgro M, Dinh E, Wehrle C, Worley MJ, Doran N. A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol-Dependent Men. Alcohol Clin Exp Res. 2017 Jan;41(1):197-206. doi: 10.1111/acer.13279. Epub 2016 Dec 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
180
June 2015
November 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects will be included if they:

  • are 18-70 years of age, inclusive;
  • are male outpatients with a diagnosis of DSM-IV-TR nicotine dependence and alcohol dependence in early full remission (1-36 months abstinence);
  • are current tobacco smokers who smoke an average of 10 or more cigarettes per day in the two months prior to the screening visit;
  • are motivated to try to quit smoking and maintain abstinence from alcohol and other illicit drugs;

Exclusion Criteria:

Subjects will be excluded if they:

  • have any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, or thyroid disease;
  • have a current significant neurologic, hepatic, renal, gastrointestinal, pulmonary, metabolic, cardiovascular, infectious, or endocrine disease;
  • have a history of known hypersensitivity to topiramate;
  • in the investigator's judgment, pose a current suicidal or homicidal risk;
  • have taken any investigational drug within 30 days of baseline; and
  • have a current seizure disorder or a history of severe alcohol withdrawal (alcohol withdrawal seizures, hallucinations / illusions, delirium tremens).
Sexes Eligible for Study: Male
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00802412
NEUA-003-08S
Yes
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Robert M. Anthenelli, MD VA San Diego Healthcare System, San Diego, CA
VA Office of Research and Development
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP